Ọgwụ ọhụrụ Nectin-4 ADC ezubere iche (9MW2821) gụnyere na ọgwụgwọ mmepe

Na Jenụwarị 8, 2025, Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA) na China nyere 9MW2821 Breakthrough Therapy Nomination (BTD). E nyere 9MW2821 yana toripalimab, antibody anti-PD-1 monoclonal, maka ọgwụgwọ-enweghị isi, nke a na-apụghị iwepụ, nke dị elu n'ógbè ma ọ bụ nke metastatic urothelial carcinoma (la/mUC).

Banyere 9MW2821

9MW2821 bụ ọgwụ mbụ e ji aka hazie nke a na-akpọ Nectin-4-targeting ADC nke Mabwell mepụtara site na iji ikpo okwu ADC na ikpo okwu nchọpụta molekul hybridoma nke nwere ike ime ihe ngwa ngwa, ọ bụkwa ọgwụ mbụ e tinyere n'ọmụmụ ihe gbasara ọgwụ n'etiti ọgwụ Nectin-4 nke ụlọ ọrụ China mepụtara, nakwa ọgwụ mbụ e ji aka rụọ nke na-achọ Nectin-4 n'ụwa iji kpughee data gbasara ọrịa kansa cervical, kansa esophageal na kansa ara. E nyere 9MW2821 aha Fast Track (FTD) maka ọgwụgwọ nke ọrịa kansa squamous esophageal dị elu, nke na-emegharị ugboro ugboro, ma ọ bụ nke na-eme ka ọ dị njọ na Febụwarị 2024, ma nyekwa Orphan Drug Designation (ODD) na FTD n'usoro maka ọgwụgwọ nke ọrịa kansa esophageal na ọrịa kansa cervical na-emegharị ugboro ugboro ma ọ bụ nke na-eme ka ọ dị njọ na-aga n'ihu ma ọ bụ na-esochi ọgwụgwọ mbụ ya site na iji usoro ọgwụgwọ chemotherapy nke dabeere na platinum na Mee 2024.

A kọrọ nsonaazụ nke ọmụmụ ihe gbasara ọgwụgwọ nkebi nke I/II site na iji 9MW2821 maka ọtụtụ etuto siri ike dị elu na Nzukọ Annual nke American Society of Clinical Oncology (ASCO) nke 2024.

Dịka ọ dị na Eprel 1, 2024, n'ime ndị ọrịa 240 nọ na otu ọgwụ 1.25 mg/kg n'ule ahụike nke Usoro nke Abụọ:

Ọrịa kansa urothelial (UC)

N'ime ndị ọrịa iri atọ na asaa a tụlere maka nyocha arụmọrụ, ọnụego nzaghachi ebumnuche (ORR) na ọnụego njikwa ọrịa (DCR) bụ 62.2% na 91.9%, n'otu n'otu, ebe ndụ ndụ na-enweghị ọganihu (mPFS) bụ ọnwa 8.8 na ndụ ndụ zuru oke (mOS) bụ ọnwa 14.2.

Ọrịa Kansa nke Eriri Oyi (CC)

N'ime ndị ọrịa iri ise na atọ a tụlere maka nyocha arụmọrụ, e jiri ọgwụ chemotherapy nke dabeere na platinum na bevacizumab gwọọ 51% na mbụ, ebe 58% natara ọgwụ chemotherapy nke dabere na platinum na ihe mgbochi mgbochi ahụ, ebe ORR na DCR bụ 35.8% na 81.1%, n'otu n'otu. MPFS dị ọnwa 3.9, ebe a naghị erute mOS. N'ime ndị ọrịa nwere oke ntụpọ mkpụrụ ndụ Nectin-4 nke 3+, ORR bụ 43.6% n'ime ndị ọrịa 39 a na-enyocha.

Ọrịa Kansa Esophageal (EC)

N'ime ndị ọrịa 39 a tụlere maka nyocha arụmọrụ, ORR na DCR bụ 23.1% na 69.2%, n'otu n'otu, na mPFS nke ọnwa 3.9 na mOS nke ọnwa 8.2; 37 n'ime ha ka ejiri ọgwụ chemotherapy na immunotherapy dabere na platinum gwọọ na mbụ.

Ọrịa Kansa Ara Atọ Na-adịghị Mma (TNBC)

N'ime ndị ọrịa iri abụọ nwere kansa ara nke nwere ike ibute ọrịa kansa ugboro atọ ma ọ bụ karịa, nke a na-enyocha maka nyocha arụmọrụ, ORR na DCR bụ 50.0% na 80.0% n'otu n'otu. MPFS dị ọnwa 5.9, a kabeghịkwa mOS, otu onye ọrịa nwetara nzaghachi zuru oke (CR) ma nọrọ na CR ruo ọnwa 20 ma ugbu a ọ na-anọgide na-abụ CR.

Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.

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Ntụaka

1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

2.Mabwell - Chọpụta Ndụ, Uru Ahụike

3.9MW2821, ọgwụ mgbochi nectin-4 (ADC), n'ime ndị ọrịa nwere etuto siri ike dị elu: Nsonaazụ sitere na ọmụmụ nkebi 1/2a. | Journal of Clinical Oncology (ascopubs.org)